FDA.report

NA

Primary DI
04055207018439
Brand
NA
Company
Richard Wolf GmbH
Model
8650664
Catalog number
8650.664
Device description
OPT.STONE GRASP.FORCEPS CVD. DOWNWARDS double-action, for grasping and crushing small calculi, for sheaths from 23Fr, for telescope 0° Ø 4mm, with twist lock, reusable
Published
2022-08-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FFLDISLODGER, STONE, BASKET, URETERAL, METAL

Product Code Classifications

CodeDeviceSpecialtyClass
FFLDislodger, Stone, Basket, Ureteral, MetalGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207018439PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207018439040552070184394055207018439

GMDN Terms

TermDefinition
Rigid endoscopic stone-retrieval forceps, reusableA rigid manual device intended to be inserted through the working channel of a compatible endoscope to grasp and remove stones (e.g., calculi from the urinary tract) or foreign bodies during an endoscopic procedure. It is typically a very long instrument with one sliding and one stationary rod, or a sheath, whose distal ends are equipped with thin grasping claws in which the stone is seized and held for extraction. The claws are typically operated by scissors-like ring handles at the proximal end of the instrument. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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03600040955727Dormia N.StoneColoplast A/SFFL2024-04-05
03600040955758Dormia N.StoneColoplast A/SFFL2024-04-05
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